| Public Health Service Food and Drug Administration |
San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700 |
Department of Health and Human Services
WARNING LETTER
Via UPS
February 18, 2011
Russell B. Altman
www.nutrasilver.com
Beneficial Solutions, LLC
1648 Lone Oak Trail
Reno, NV 89523
Dear Mr. Altman:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.nutrasilver.com. as well as other labeling promoting your product, "NutraSilver," and has determined that NutraSilver is promoted for conditions that cause your product to be a drug under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)(B)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the product with these claims violates the Act. You can find the Act and its implementing regulations through links on FDA's website, www.fda.gov.
Examples of some of the claims observed on the website www.nutrasilver.com include:
Claims on homepage:
• "NutraSilver ... kills pathogens including bacteria, viruses, fungus/yeast and single-cell parasites."
Claims on webpage titled "Safety & Research":
• "These pathogens were utterly destroyed by NutraSilver in FDA-certified lab tests.:
o eColi
o Salmonella
o Candida albicans
o MRSA (Methicillian [sic] Resistant Staphylococcus Aureus) ..."
Claims on webpage titled "Kid's General Health":
• "NutraSilver kills viruses so you either avoid a cold or flu completely, or as many Nutrasilver customers have shared with us, their cold or flu symptoms last less than half as long as those who do not take NutraSilver."
• "Many NutraSilver® customers have told us that NutraSilver will eliminate sinus infections very quickly."
• "One or two treatments is all that is necessary to eliminate the sinus infection."
Claims on webpage titled "Disease Prevention":
• "Sufficient NutraSilver taken daily precludes infection, viruses, disease, contagion outbreak and serious burn toxicity."
• "[E]ffectively kills the many thousands of viruses and bacteria that are present throughout the body. In addition, it lessens the toxicity due to the average amount of virus and bacterial activity that occurs naturally in the body."
• "NutraSilver, when taken daily, kills harmful bacteria, viruses and fungus quickly and safely."
Claims on webpage titled "MRSA Disease Treatments":
• "NutraSilver is a fast and effective MRSA/MERSA Disease Treatment"
• "Unlike antibiotics, Nutrasilver kills viruses, bacteria and fungal infections."
• "NutraSilver can be a safe, effective and comfortable experience eliminating MRSA from the body without allergic reactions or any other life-threatening side effects known to exist using current antibiotics therapies."
Claims on webpage titled "Lyme Disease Pictures":
• "NutraSilver is Proven to Eliminate Lyme Disease Symptoms"
• "We know that NutraSilver will eliminate your Lyme Disease symptoms."
Your website also contains disease claims in the form of personal testimonials, including:
Testimonials on webpage titled "MRSA Testimonials":
• "I was extremely sick with my MRSA since 2005 ... .I have not had one single down day since I've been taking NutraSilver. I no longer take 6 hour naps during the day (after a full nights rest), my rashes & boils disappeared entirely, sinus congestion & migraines no longer hit me (NOT even ONE since I started this), I no longer have any monster-sized gland swelling in my neck or bad ear infections."
• "NutraSilver has brought me back to LIFE. It's literally wiped out ALL of my MRSA symptoms...."
Testimonials on webpage titled "Great Ideas for Home Uses"
• "I use NutraSilver with a nebulizer to fight flu's, coughs, colds and sore throats."
Testimonials on web page titled "Other Testimonials":
• Under the heading "Common Cold Remedy": "NutraSilver seems to be the most powerful [product] I have tried Normally my colds seem to take 7-12 days to overcome and with NutraSilver it's over in usually 6-8 days and the severity is not as bad."
• Under the heading "Celiac Disease -Susan": "Well, I have finished my round of NutraSilver. Two weeks and I have to say I do feel better. ... I can hug my grand daughters [sic] and not wince from the pain of their touch. So yes I do conclude that this product is helping me."
In addition to the claims on your website, the following claims appear in a tri-fold brochure that was included with the shipping package of an order of NutraSilver:
• "NutraSilver hunts down harmful pathogens including bacteria, viruses, fungus/yeast and single-cell parasite. Then NutraSilver switches off the pathogen's ability to breath [sic]. The pathogen suffocates and dies in about 5 minutes."
• "FDA-CERTIFIED LABS have tested NutraSilver against Staph, MRSA, e-Coli, Salmonella, Cholera, Candida and many more potentially deadly pathogens. Billions of cells were tested and all showed a 99.99% or better kill rate. MRSA was killed in 60 seconds at 99.9999%!"
• "Symptoms that have been with you for years slowly disappear providing relief. Relief from: ...
o Lyme Disease
o MRSA
o Candida
o Staph Infection
o Fungus/Yeast ...
o Food Poisoning"
Your product, NutraSilver, is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, because your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use the product safely for its intended uses. Thus, NutraSilver is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that its labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your product do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to U.S. Food and Drug Administration; Attn: Carl Lee, Compliance Officer; 1431 Harbor Bay Parkway, Alameda, CA 94502. You may reach Carl Lee at (510) 337-6737.
Sincerely,
/S/
Barbara Cassens,
District Director,
San Francisco District
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